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Completed

NCT Number: NCT04427202

Ending Transmission of HIV, HCV, and STDs and Overdose in Rural Communities of People Who Inject Drugs (ETHIC)

This study will evaluate the referral to harm reduction services (HRS) including syringe services, naloxone overdose prevention, substance use treatment referral, HIV, HCV, and STD testing and referral and linkage to care through capacity building of existing programs through client services data.

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Key information

Conditions

HIV Blood-Borne Infections Chemically-Induced Disorders Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis C Hepatitis, Viral, Human Infections Injection Drug Use Liver Diseases Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Opioid-use Disorder RNA Virus Infections Substance-Related Disorders Virus Diseases

Age range

15 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Southern Illinois University, Carbondale, Illinois, United States

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About this study

This is a prospective longitudinal Type 1 Hybrid Implementation Effectiveness Study on the expansion of harm reduction services for people who inject drugs (PWID) and people who use opioids (PWUO) residing in high risk areas of rural southern Illinois. This study record describes one component of the larger Ending transmission of HIV, HCV, and STDs and overdose in rural communities of people who inject drugs (ETHIC) study Community Response Plan (CRP) framework, specifically the expansion of harm reduction services intervention (HRS). The aim is to assess the effectiveness of expansion of evidenced based harm reduction services through our CRP framework comprising: a) geographically targeted recruitment based on hot spot and vulnerability analyses, b) community engagement, c) recruitment via Respondent Driven Sampling (RDS), d) expanded surveillance for HIV and HCV, and e) concomitant HCV and opioid use treatment capacity expansion through the Extension of Community Healthcare Outcomes (ECHO) model. Examination of facilitators and barriers impacting implementation of service delivery is evaluated through mixed methods process evaluation. The Type 1 Hybrid design is supported by conditions including the existing evidence based for benefits and minimal harm of "harm reduction services" and strong base for applicability of this intervention in the study setting (ie rural opioid use)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 15 years of age and older
  • Injected any drug in the past 30 days
  • Used any opioids non-medically in the past 30 days
  • English speaking
  • Able to provide informed consent at the time of the study visit

Exclusion criteria

  • Less than 15 years of age
  • Not injected any drug in the past 30 days
  • Not used any opioids non-medically in past 30 days
  • Non-English speaking
  • Has not injected any opioid drug to get high in the past 30 days
  • Unable to provide informed consent at the time of the study visit

Treatment and study plan

Referral to harm reduction services

Behavioral

Participants are referred to harm reduction services

Primary outcomes

  1. Total Participants Who Received Referrals to the Harm Reduction Services Organization

    Time frame: 2 years

    Number of participants who accept referral to the intervention (divided by the total enrolled who did not have previous engagement prior to the study with the harm reduction services organization).

Secondary outcomes

  1. Number of Locations Where Participants Received Most of Syringes or Needles

    Time frame: 2 years

    Number of unique zip codes that participants received most of their syringes or needles based on mobile unit delivery.

  2. Number of Times Sterile Syringes and/or Equipment Obtained From an Intervention

    Time frame: 2 years

    This was counted as the number of visits made by the hard reduction service organization to distribute sterile syringes and/or equipment.

  3. Number of Times Participants Used a Syringe or Needle That They Knew Was Used by Somebody Else

    Time frame: 2 years

    "How many times (encounters) in the past 30 days did you inject using a syringe or needle that you know had been used by somebody else?"

  4. Number of Times Participants Used a Cotton, Cooker, Spoon, or Water for Rinsing or Mixing That They Knew Was Used by Somebody Else

    Time frame: 2 years

    "How many times (encounters) in the past 30 days did you use a cotton, cooker, spoon or water for rinsing or mixing that you know had been used by somebody else?"

  5. Number of Times Participants Let Someone Else Use a Cotton, Cooker, Spoon, or Water for Rinsing or Mixing After They Used it

    Time frame: 2 years

    "How many times (encounters) in the past 30 days did you let someone else use a cotton, cooker, spoon, or water for rinsing or mixing after you used it?"

  6. Number of Participants With Drive Time Less Than 30 Minutes to Nearest Syringe or Needle Exchange

    Time frame: 2 years

    Number of participants with drive time less than 30 minutes to nearest syringe or needle exchange.

  7. Number of Participants That Currently Have Naloxone

    Time frame: 2 years

    "Do you currently have naloxone or Narcan with you or at home?"

  8. Number of Participants Who Received Substance Use Disorders (SUD) Treatment Referrals

    Time frame: 2 years

    Total number of participants who received a substance use disorder referrals made by the hard reduction services organization.

  9. Total Number of Participants Who Received an HIV Screening

    Time frame: 2 years

    Total number of tests that participants screened for HIV, from baseline to follow-up.

  10. Total Number of Participants Who Received an HCV Screening

    Time frame: 2 years

    Total participants screened for HCV at least once during baseline and follow-up. For those who had a HCV reactive test were then later referred to further services.

  11. Number of Participants With Knowledge of PrEP

    Time frame: 6 months

    "Have you ever heard of medicine people can take to prevent HIV?"

  12. Number of Participants Diagnosed With HIV Who Have Access to HIV Care

    Time frame: 2 years

    Total number of participants who were newly diagnosed with HIV during the study period.

  13. Number of Participants Diagnosed With HCV Who Have Access to HCV Care

    Time frame: 2 years

    Total number of participants who were newly diagnosed with chronic Hep C who were referred to Hep C care.

  14. Number of Times a Participant Engaged in Condomless Sex (Vaginal or Anal)

    Time frame: 6 months

    "In the last 30 days, how many times did you have vaginal or anal sex without a condom?"

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Collaborators

  • Community Action Place, Inc.
  • National Institute on Drug Abuse (NIDA)
  • New York University
  • Southern Illinois University
  • University of Illinois at Chicago
  • University of Washington

Registry information

Acronym: ETHIC

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jun 11, 2020
Registry last updated
Dec 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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